UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051654 |
|---|---|
| Receipt number | R000058875 |
| Scientific Title | Estimation of Socioeconomic Burden of Adult Attention-Deficit/Hyperactivity Disorder (ADHD) in Japan |
| Date of disclosure of the study information | 2023/07/20 |
| Last modified on | 2023/07/13 11:03:11 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Estimation of Socioeconomic Burden of Adult Attention-Deficit/Hyperactivity Disorder (ADHD) in Japan
Acronym
Socioeconomic costs of adult ADHD in Japan.
Scientific Title
Estimation of Socioeconomic Burden of Adult Attention-Deficit/Hyperactivity Disorder (ADHD) in Japan
Scientific Title:Acronym
Socioeconomic costs of adult ADHD in Japan.
Region
| Japan |
Condition
Condition
Attention-Deficit/Hyperactivity Disorder (ADHD)
Classification by specialty
| Psychiatry |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to estimate the socioeconomic burden of adult ADHD in Japan per year.
Basic objectives2
Others
Basic objectives -Others
The purpose of this study is to estimate the socioeconomic burden of adult ADHD in Japan per year. The socioeconomic burden includes the costs of healthcare resources and social security services utilized by adult ADHD patients, productivity loss in adult ADHD patients, and productivity loss in adult family members of adult ADHD patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Socioeconomic Burden of Adult ADHD
The costs of medical care, social security services, and productivity loss (the cost of lost employment, reduced salary and reduced work productivity defined by absenteeism and presenteeism) in adult ADHD patients and productivity loss in adult families of adult ADHD patients and their aggregate values are estimated.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
web-based questionnaire Survey
-Those who were willing to participate in the survey, understood the contents of the informed consent form for the survey, and gave consent to participation in the survey
-Male or female patients >= 18 to < 65 years of age at the time of informed consent.
-The subject are living in Japan at the time of the questionnaire.
Inclusion criteria for each study population are as follows:
-Adult ADHD patients: individuals who have diagnosis of ADHD
-Adult families of adult ADHD patients: individuals who do not have diagnosis of ADHD, family members living together are diagnosed with ADHD and aged 18 years or older.
-ASRS-positive non-ADHD adults: individuals who do not have diagnosis of ADHD, family members living together have not been diagnosed with ADHD, and ASRS*-positive(>= 4)**
-ASRS-negative non-ADHD adults: individuals who do not have diagnosis of ADHD, family members living together have not been diagnosed with ADHD, and ASRS negative(< 4)
**At least 4 out of 6 questions about symptom frequency in Part A of the Japanese version of the Adult ADHD Self-Report Scale (ASRS, v1.1) are above the prespecifi edcriteria.
Database analysis
-Patients diagnosed with 'other mental and behavioral disorders' (including ADHD), and having a health insurance claim in the JMDC database
-Patients registered in the JMDC database for the year to be analysed
-For ADHD, the patients aged >= 18 and < 65 years in the year to be analysed
Key exclusion criteria
A web-based questionnaire Survey
-Not applicable
Database analysis
-Not applicable
Target sample size
1800
Research contact person
Name of lead principal investigator
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nishigaki |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Offi ce
Zip code
103 - 8668
Address
2-1-1 Nihonbashi Honcho, Chuo-ku, Tokyo
TEL
03-3278-2111
nobuhiro.nishigaki@takeda.com
Public contact
Name of contact person
| 1st name | Nobuhiro |
| Middle name | |
| Last name | Nishigaki |
Organization
Takeda Pharmaceutical Company Limited.
Division name
Japan Medical Offi ce
Zip code
103 - 8668
Address
2-1-1 Nihonbashi Honcho, Chuo-ku, Tokyo
TEL
03-3278-2111
Homepage URL
nobuhiro.nishigaki@takeda.com
Sponsor or person
Institute
Takeda Pharmaceutical Company Limited.
Institute
Department
Personal name
Funding Source
Organization
Takeda Pharmaceutical Company Limited.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
NPO MINS Institutional Review Board
Address
ST Shibuya Building 2F, 1-15-14 Dogenzaka, Shibuya-ku, Tokyo
Tel
03-6416-1868
npo-mins@j-irb.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2023 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 07 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2023 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 07 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058875
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
